PROBLEM STATEMENT
Challenges in Manual
Training Process
GMPs mandate that people be taught the GMP requirements that are
applicable to their activities. Each employee has to be trained in the
exact process or operation he/she is involved in. GMP training also
establishes requirements for continuous training and its practical
effectiveness periodically assessed.
Development & implementation of GMP training is time taking
Increasing US FDA observations on Procedure not written & fully followed
Define Learner Roles for Role-based Training
Re-training the employee and re-viewing the procedure
Deploy Training and retraining for published and updated documents
Generate Insight and Take Action based on skills, course completed etc.
Inefficient Competency Assessment
GMP training record retention incurs a huge cost

How
AmpleLogic
Learning
Management
Solution
Enables you
to
Strategies
&
Execute
GMP training
Compliance
Ready
Automates all activities, from distribution of tasks, materials,
and exams to follow-up, tracking, escalation, and verification
Creation of multi-format training content with SCORM
standards including controlled document, videos, image etc.
Provides skill matrix up-to-date view grouped by skill, roles
or department
Revisions in training material (SOPs) can automatically
trigger a notifications and reminder alert to learners
Testing, grading, and documentation of each user’s training
history, with attached training record evidence
Develop your own database of policies, procedures,
assessments, and training to provide measurable results

Tracking Learning Session
COMPLIANCE READY FEATURES
 Formal and Informal Learning
 Classroom and on-the-job
 In person, virtual and digital
 Events or Trainings attended
outside of the organization
Course Versioning and Upgrading
 Track course versions not only in
content but also in prerequisites,
materials, and delivery
 Visibility on which version a
particular learner enrolled
 Course updates automatically
credits the learner to the new
version
 Track courses, programs or
certifications that requires renewal,
and when those renewals need to
occur.
 Reporting engine to create custom
reports to meet unique needs
Reporting Options
A High level Training Flowchart

TRAINING MASTER
Training Material
Training Courses
Course Questionnaire
Course Certification
COURSE ASSIGNMENT
Course Management
Course Group
User Group
Course - User Group Mapping
Nominate for GMP Courses
Job Roles & Responsibility
TRAINING PLANNER
GMP Yearly Training Planner
OJT Yearly Training Planner
Annual & Monthly Calendar
AMPLELOGIC LEARNING MANAGEMENT SYSTEM FEATURE LIST
TRAINING SESSIONS
Self Reading & Classroom Sessions
Practical Sessions
Instructor Led Training (ILT) Session
External Training Classroom Record
Initial / Induction Training
Employee Orientation Program
Auto Scheduling of Sessions
Re-training Session
SNAP Test Module
EMPLOYEE
Learning Path
Self Enrollment
Competency Matrix
To Do List Activities
Job Role / Training Acknowledgement
EVALUATION
Skill Matrix
Employee Training Card
Exam Results
Employee Qualification
Trainer Qualification
REPORTS
Employee Wise Training Completion
Course Applicability Department Wise
Total Training Hours
Department Wise Training Status
GAP Analysis Report
Defaulters Training / Department wise
Course Reports
Initial Training Status Reports
20+ custom reports
WHY AMPLELOGIC ?
Customized Workflow
Role Based Access
Custom Reports and Dashboards
User Permission & Restrictions
Scheduler Configuration
Alert Management
Integration to Quality System
Integration to Active Directory
Biometric Access and Integration
Application Session Management
Login & Password Policy & Checks
Adaptable to Mobile & Tablets
SCORM Standards
Master Data Maintenance
Multi Lingual Content – UI Available

REGULATORY
COMPLIANCE
FEATURES
AmpleLogic solutions are compliant
to meet the requirements of
regulatory bodies like FDA’s 21 CFR
Part 11, EU Annex, MHRA etc.
Audit Trial
Digital / Electronic Signature
Access Authentication
Record Audit
Copies of Records
View History

Solution Integration for coherent business processes
Learning Management System is integrated with key GxP systems providing data to develop enterprise-wide strategy for
learning development. Integration also remove redundant manual efforts that can be time-consuming and automates
some processes. i.e, integration with DMS to support SOP version control and automatic new training creation.
QUALITY SYSTEMS MANUFACTURING SYSTEMS

2010 Operations Started in Hyderabad India
2012 First GMP Implementation of Audit Module using LOW CODE PLATFORM
2014 ISO 9001-2015 Certification
Associated with 10 leading pharma companies for DMS and QMS implementations
Signed up with 7 leading Pharma Companies2015
2016 Recognized by CIO review magazine and Silicon India for unique delivery models
Launched QC automation modules and LMS solution
2017 Associated with 25 US FDA/MHRA/WHO approved Plants
2018 Finalist in CPHI Worldwide Awards, Entry into Egypt and UAE Markets
Foundation to develop new modules like APQR, Product Recall, ANDA & DMF tracker
Started working on draft Quality Metrics guidelines by USFDA
2019 US Market entry, Appreciated by 7 customers during audit on our Paperless automation
120 Young Engineers, 10,000 Sq. feet offices and 3 channel partners
Road map to add more flexibility to eBMR/MES, eLogs
About AmpleLogic
Trusted
by
35+ Pharma
&
20 Non Pharma
Companies across
Globe

Pharmaceutical Business Process - Ready to Use Modules
16 6 6 7 17 1 2
No of Implementations
Yet to Launch

Our Customers
Pharma and Biotech
Non Pharma

Any Queries?
Please Contact us: info@amplelogic.com
Visit Us : https://amplelogic.com/
Thank You